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510(k) Data Aggregation

    K Number
    K090688
    Device Name
    COOK UROLOGICAL GRAFT
    Manufacturer
    COOK BIOTECH, INC.
    Date Cleared
    2009-07-10

    (116 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.
    Device Description
    The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.
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    K Number
    K050445
    Device Name
    AMS COLLAGEN DERMAL MATRIX
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2005-06-17

    (115 days)

    Product Code
    PAG, FTM, PAI, PAJ
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse. The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
    Device Description
    The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes. The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling. The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall. The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.
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    K Number
    K042949
    Device Name
    PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2004-11-09

    (14 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue membranes. It is specifically indicated for use in the surgical repair of tissue resulting from damaged or ruptured soft tissue and for the inhibition of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The Bard® PelviLace™ TO BioUrethral Support System consists of the PelviLace Pelvicol implant and introducers. The introducers are used to place the implant which provides a natural backboard for the urethra during abdominal pressure increases.
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    K Number
    K031295
    Device Name
    BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2003-05-15

    (22 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases. The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.
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    K Number
    K030460
    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2003-03-07

    (23 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    (Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
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    K Number
    K020654
    Device Name
    STRATASIS SLING KIT
    Manufacturer
    COOK BIOTECH, INC.
    Date Cleared
    2002-04-09

    (40 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.
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    K Number
    K993459
    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    1999-11-05

    (23 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    [Trade name] is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
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    K Number
    K992159
    Device Name
    SURGISIS SLING
    Manufacturer
    COOK BIOTECH, INC.
    Date Cleared
    1999-09-23

    (90 days)

    Product Code
    PAG, FTM, PAJ
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.
    Device Description
    The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.
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    K Number
    K982403
    Device Name
    BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    1998-09-22

    (74 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    PAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    Brennen Biosynthetic Surgical Mesh Matrix
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